F511 Cream in Preventing Palmar-Plantar Erythrodysesthesia in Patients Receiving Doxorubicin Hydrochloride Liposome for Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

Local Antiperspirant for Prevention of Palmar-Plantar Erythrodysesthesia (PPE) in Patients Treated With Pegylated Liposomal Doxorubicin: A Randomized, Multicenter, Double Blinded, Phase III Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00992706
• Other study ID #: SAKK 92/08
• Secondary ID: SWS-SAKK-92/08EU
• Status: Completed
• Phase: Phase 3
• Start date: September 2009
• Est. completion date: June 2012

Study information

• Verified date: May 2019
• Source: Swiss Group for Clinical Cancer Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: F511 cream may prevent or reduce palmar-plantar erythrodysesthesia in women receiving doxorubicin hydrochloride liposome for metastatic breast cancer.

PURPOSE: This randomized phase III trial is studying F511 cream to see how well it works compared with a placebo cream in preventing palmar-plantar erythrodysesthesia in patients receiving doxorubicin hydrochloride liposome for metastatic breast cancer.

Description:

OBJECTIVES:

• Evaluate the effects of F511 cream on the occurrence of palmar-plantar erythrodysesthesia (PPE) in patients with metastatic breast cancer treated with pegylated liposomal doxorubicin hydrochloride.

OUTLINE: This is a multicenter study.

Patients receive pegylated liposomal doxorubicin hydrochloride according to local practice on 1, 2, or 4 weeks course schedules with at least 10 mg/m^2 per week allowed.

Patients apply F511 cream on one side, hand and foot and the corresponding placebo on the other side hand and foot once daily (the morning) during the first week of the first pegylated liposomal doxorubicin hydrochloride treatment only, then once daily, three times per week thereafter. Treatment continues throughout chemotherapy administration in the absence of palmar-plantar erythrodysesthesia (PPE) ≥ grade 2

After completion of study therapy, patients are followed for 30 days. Patients with PPE ≥ grade 2 are followed until the PPE resolves to ≤ grade 1.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: June 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of metastatic breast cancer

• No cutaneous metastases on hands or feet

• Pegylated liposomal doxorubicin hydrochloride monotherapy is indicated according to the local investigator

• Planned dose at least 10 mg/m^2 per week

• No sign of palmar-plantar erythrodysesthesia (PPE) at study entry

PATIENT CHARACTERISTICS:

• WHO performance status 0-2

• Able to apply topical medication (cream) or provide for another person to apply cream

• Not pregnant or breastfeeding

• Fertile patients must use effective contraception during trial participation and for 1 month after completion

• Negative pregnancy test

• Compliant and geographically proximal in order to allow proper evaluation and follow-up

• No dermatologic conditions (e.g., psoriasis) that, in the opinion of the physician, may affect the hands or feet or may complicate evaluation during study treatment

• No known allergy or hypersensitivity to F511 cream

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• More than 30 days since prior and no concurrent treatment with other experimental drugs or anticancer therapy

• More than 30 days since prior and no concurrent treatment on another clinical trial

• No concurrent local use of other ointments or creams for hands or feet other than Excipial Repair®

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Hand-Foot Syndrome
• Palmar-plantar Erythrodysesthesia

Intervention

Drug:
• antiperspirant cream F511
Placebo and verum cream once daily, in the morning, during the first week of the first PLD treatment only, then once daily, three times per week (in the morning). Tube R for right hand and foot, tube L for left hand and foot.
• pegylated liposomal doxorubicin hydrochloride
According to local practice. 1, 2 and 4 week schedules with at least 10mg/m2 per week are allowed.

Locations

Country	Name	City	State
Switzerland	Kantonsspital Aarau	Aarau
Switzerland	Kantonsspital Baden	Baden
Switzerland	Universitaetsspital-Basel	Basel
Switzerland	Spitalzentrum Biel	Biel
Switzerland	Spital Buelach	Bulach
Switzerland	Kantonsspital Graubuenden	Chur
Switzerland	Hopital Cantonal Universitaire de Geneve	Geneva
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
Switzerland	Kantonsspital Luzern	Luzerne
Switzerland	Kantonsspital Olten	Olten
Switzerland	Onkologie Schaffhausen	Schaffhausen
Switzerland	Institut Central des Hopitaux Valaisans	Sion
Switzerland	Kantonsspital - St. Gallen	St. Gallen
Switzerland	Kantonsspital Winterthur	Winterthur
Switzerland	UniversitaetsSpital Zuerich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Group for Clinical Cancer Research

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Templeton AJ, Ribi K, Surber C, Sun H, Hsu Schmitz SF, Beyeler M, Dietrich D, Borner M, Winkler A, Müller A, von Rohr L, Winterhalder RC, Rochlitz C, von Moos R, Zaman K, Thürlimann BJ, Ruhstaller T; Swiss Group for Clinical Cancer Research (SAKK) Coordin — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Palmar-plantar erythrodysesthesia (PPE, hand-foot syndrome, HFS) grade = 2		Until PPE grade =2
Secondary	Patient-reported outcome		Until PPE grade =2
Secondary	Adverse skin reaction to local therapy		Until PPE grade =2
Secondary	Extent of symptom relief		Until PPE grade =2
Secondary	Recurrence of PPE grade = 2		Until PPE grade =2